The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction

NCT05424666 | Unknown

• 1 other identifier: Oncoplastic breast surgeries
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The Role of Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction

Conditions

Cancer, Breast

Outcome Measures

Primary Outcomes (1)

• Cosmetic apperance

  Volumetric evaluation of breast after surgery and symmetry to the other breast

  1 week

Secondary Outcomes (1)

• Complications during the treatment and follow up

  1 month

Study Arms (1)

Patient going Oncoplastic Breast surgeries

EXPERIMENTAL

Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction

Procedure: Harvesting method and Fat graft preparation method

Interventions

Harvesting method and Fat graft preparation method PROCEDURE

The procedure begins by identifying the areas where the fat will be collected Then the sample is collected by micro-incision using a fine suction cannula or during conventional liposuction. The fat cells are taken from an area of the body where there is a reserve (generally, in the abdomen, hips, knees, inner thighs, buttock) The collected fat cells are then subjected to a sterile centrifugation for a few minutes so as to separate the cells that will be injected (intact fat cells) from the elements that must not be injected (fat cells destroyed by the sample, non-fat cells such as than blood cells). Injection of fat cells into the breasts The reinjection of fat (lipofilling) is performed using micro-cannulas allowing incisions of the order of 1-2 mm in different angles and in multiple directions so as to increase the contact area between the grafted cells and the recipient tissues allowing a "good grip" of the injection.

Patient going Oncoplastic Breast surgeries

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female gender.
• Age of 18 years and older.
• History or in candidate for a mastectomy in the near future.
• Patients undergoing prophylactic mastectomy.
• Patients' choice to undergo a breast reconstruction.
• Wanting to participate in this study.
• Patient is able to wear the BRAVA (BRA like VAcuum-based external tissue expander) device.

You may not qualify if:

• Active smoker or a history of smoking 4 weeks prior to surgery.
• Current substance abuse.
• History of lidocaine allergy.
• Four weeks or less after chemotherapy.
• History of radiation therapy in the breast region.
• Oncological treatment includes radiotherapy after mastectomy.
• Kidney disease.
• Steroid dependent (daily or weekly).
• Immune-suppressed or immune-compromised disease.
• Uncontrolled diabetes.
• body mass index of \>30.
• Large breast size (ie, larger than cup C), unless the patient prefers reduction of the contralateral side towards cup C.
• Extracapsular silicone leaking from the encapsulated implant from a previous breast reconstruction.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut lecturer

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: June 21, 2022
• Study Start: December 19, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3 years
• Access Criteria: Assiut university

Locations

EG (1)